A randomized, double blind, placebo and active comparator controlled pilot study
of UP446, a novel dual pathway inhibitor anti-inflammatory agent of botanical
origin.
Author(s): Sampalis JS, Brownell LA.
Affiliation(s): JSS Medical Research Inc., Montreal, Quebec, Canada.
Publication date & source: 2012, Nutr J. , 11:21
BACKGROUND: Current use of prescribed or over the counter non-steroidal
anti-inflammatory drugs (NSAIDs) for pain and osteoarthritis (OA) have untoward
gastrointestinal and cardiovascular related side effects, as a result the need
for a safe and effective alternative has become unequivocally crucial.
METHOD: A randomized, double blind, placebo and active controlled pilot study of
a novel dual pathway, COX1/2 and LOX, inhibitor anti-inflammatory agent of
botanical origin, UP446 was conducted. Sixty subjects (age 40-75) with
symptomatic OA of the hip or knee were assigned to 4 treatment groups (n = 15);
Group A0 (Placebo, CMC capsule), Group A1 (UP446 250 mg/day), Group A2 (UP446 500
mg/day) and Group A3 (Celecoxib, 200 mg/day). MOS-SF-36 and Western Ontario and
McMaster University Osteoarthritis Index (WOMAC) data were collected at baseline
and after 30, 60 and 90 days of treatment as a measure of efficacy. Erythrocyte
sedimentation rate, C-reactive protein, plasma thrombin time (PTT), fructosamine,
Hematology, clinical chemistry and fecal occult blood were monitored for safety.
RESULTS: Statistically significant decrease in WOMAC pain score were observed for
Group A1 at day 90, Group A2 at 30 and 90 days and Group A3 at 60 and 90 days.
Statistically significant decrease in WOMAC stiffness score were observed for
Group A1 and Group A2 at 30, 60 and 90 days; but not for Group A0 and Group A3.
The mean change in WOMAC functional impairment scores were statistically
significant for Group A1 and Group A2 respectively at 30 days (p = 0.006 and p =
0.006), at 60 days (p = 0.016 and p = 0.002) and at 90 days (p = 0.018 and p =
0.002), these changes were not significant for Group A0 and Group A3. Based on
MOS -SF-36 questionnaires, statistically significant improvements in physical
function, endurance and mental health scores were observed for all active
treatment groups compared to placebo. No significant changes suggestive of
toxicity in routine hematologies, serum chemistries, liver enzymes or PTT were
noted in any of the treatment groups.
CONCLUSION: Based on current findings UP446 is safe and efficacious alternative
to established anti-inflammatory medications for alleviating OA symptoms as
measured by the WOMAC Index.
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